{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-15",
    "results": {
      "skip": 0,
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  },
  "results": [
    {
      "cfres_id": "203404",
      "product_res_number": "Z-0137-2024",
      "event_date_initiated": "2023-09-13",
      "event_date_posted": "2023-10-22",
      "recall_status": "Open, Classified",
      "res_event_number": "93085",
      "product_code": "MWS",
      "product_description": "Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.\nProduct Code: OM-10000Z",
      "code_info": "UDI-DI: 00607567100008\nLot Numbers: 3000188485, 3000193165, 3000193670, 3000195673,\n3000198652, 3000199944, 3000201253, 3000204442",
      "firm_fei_number": "2242352",
      "recalling_firm": "Maquet Cardiovascular, LLC",
      "address_1": "45 Barbour Pond Dr",
      "city": "Wayne",
      "state": "NJ",
      "postal_code": "07470-2094",
      "reason_for_recall": "Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.",
      "root_cause_description": "Device Design",
      "action": "Maquet /Getinge issued Urgent Device Medical Device Removal (FSCA 2242352-09/06/2023-004-R) via FedEx with delivery receipt on 9/13/23. Letter states reason for recall, health risk and action to take:\nPlease examine your inventory immediately to determine if you have any of the Acrobat-i Stabilizer\nSystem with the product codes/lot numbers listed in this notice.\nIf you have unused/unexpired affected product that you will be returning from your inventory, please\ncontact Maquet/Getinge Customer Service at 888-880-2874 between the hours of 6 AM and 5 PM Pacific\nStandard Time to request a return authorization number (RMA) and shipping instructions.\nIf you have affected product, you are entitled to a credit. You will receive credit upon your\nacknowledgement that you have affected product for return.\nPlease complete and sign the attached MEDICAL DEVICE Removal - RESPONSE FORM (page 4) to\nacknowledge that you have received this notification. Return the completed form to Maquet/Getinge by emailing\na scanned copy to acrobati-mountbreak2023.act@getinge.com or by faxing the form to (877) 634-6230.\nPlease forward this information to all current and potential Acrobat-i Stabilizer System users within your hospital / facility.",
      "product_quantity": "2951 units",
      "distribution_pattern": "Nationwide\n\nForeign:\nAT\nBE\nDE\nES\nFR\nGB\nIT\nJP\nKR\nLU\nNL\nPL\nPT\nTR",
      "openfda": {
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        "fei_number": [
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          "3005747797",
          "3002998595"
        ],
        "device_name": "Stabilizer, Heart",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4500",
        "device_class": "1"
      }
    }
  ]
}